Clearance Summary
NORTEC CONNECTING TUBE SET received FDA 510(k) clearance under submission number K911865, sponsored by North American Sterilization & Packaging Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1991-11-01.
- Submission: K911865
- Applicant / Sponsor: North American Sterilization & Packaging Co.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6740
- Decision date: 1991-11-01
Classification & Regulation
This clearance is catalogued under FDA product code GAZ and 21 CFR 880.6740, within the General Hospital review panel as a Class II device.